Specialist, Digital Foundational Services (IT/OT Compliance)

Merck; United States; Remote; USD 80,000 - 100,000; Full time

Job summary

Join a leading company as a Specialist in Digital Foundational Services, focusing on IT and Operational Technology Compliance. You will manage compliance programs, ensure adherence to regulations, and collaborate with global teams to enhance organizational capabilities. This role requires strong knowledge of regulatory compliance and excellent communication skills. You will also promote automation standards and act as a Subject Matter Expert in computer validation, ensuring the quality of pharmaceuticals.

Qualifications

• 2+ years of experience in compliance activities for capital projects.
• Strong knowledge of regulatory requirements related to computerized systems validation.

Responsibilities

• Manage regulatory compliance programs and ensure adherence to policies.
• Promote automation validation standards across projects.
• Collaborate with site compliance and validation teams.

Skills

Regulatory Compliance

Collaboration

Communication

Risk Management

Education

Bachelor’s Degree in Computer Science

Bachelor’s Degree in Engineering

Bachelor’s Degree in Regulatory Compliance

Tools

Computer Systems Validation

Automation Systems

Manufacturing Analytics

Job description

Job Description

Join our dynamic IT team, where we partner with various departments to propose innovative solutions that enhance organizational capabilities. We work collaboratively across the globe to deliver services that boost productivity and foster innovation.

As a Specialist, Digital Foundational Services focusing on IT and Operational Technology Compliance, you will manage regulatory compliance programs and ensure adherence to policies and procedures. Your role will involve promoting a risk-based and efficient approach to compliance activities.

You will report to the Associate Director of Compliance and collaborate with a cluster lead for the EMEA, Asia-Pacific, or United States region.

Bring energy, knowledge, innovation to carry out the following:

• Deliver top-tier computer systems validation for capital projects.
• Promote automation validation standards across projects.
• Collaborate with site compliance and validation teams to coordinate activities.
• Ensure compliance with Computer Systems Validation, Systems Development Lifecycle, Cyber Security, and Data Integrity to maintain the quality of pharmaceuticals.
• Act as a Subject Matter Expert on computer validation for capital projects.
• Provide ongoing validation, training, and compliance support.
• Represent compliance activities to internal and external auditors.
• Assist in developing audit responses and engage with local quality organizations as needed.
• Identify and address IT and Operational Technology compliance risks.
• Conduct risk assessments for new technologies or significant changes.
• Support local teams in navigating quality and compliance challenges.
• Report on execution challenges and adherence to procedures.
• Communicate and advocate for changes to Systems Development Lifecycle policies and procedures.
• Participate in a compliance group to share knowledge and improve execution.

What skills you will need:

In order to excel in this role, you will more than likely have:

• Bachelor’s Degree in Computer Science, Engineering, Regulatory Compliance, or a related field.
• 2+ years of experience in compliance activities for capital projects.
• Strong knowledge of regulatory requirements related to computerized systems validation.
• Familiarity with ISA S95 and S88 Standards in a Good Practice environment.
• Experience validating and qualifying Cloud, Software as a Service, and data integration platforms.
• Extensive experience with automation systems and leading validation teams.
• Understanding of end-to-end manufacturing processes, including Manufacturing, Quality, and Supply Chain.
• Ability to collaborate with diverse stakeholders and manage conflicting priorities.
• Excellent written and verbal communication skills, with the ability to simplify complex concepts.
• Strategic thinker capable of navigating ambiguity and developing actionable plans.
• Self-motivated leader who can drive results with minimal direction.

• Preferred experience and skills:
  • Postgraduate qualification in Business Strategy or IT Architecture.
  • Experience in the pharmaceutical industry, particularly in Manufacturing and Supply Chain.
  • Knowledge of integrating real-time shop floor and lab systems at an enterprise level.
  • Familiarity with manufacturing analytics systems and business process re-engineering principles.

• Travel requirements:
  • Willingness to travel 10-25% for assignments outside your primary location, including short-term travel as needed.

Current Employees apply HERE

Current Contingent Workers apply HERE

Secondary Language(s) Job Description:

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.

Please feel free to speak to us about what flexibility means to you during your application.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, please apply today.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:

Audit Management, Business Processes, Business Process Modeling, Business Process Re-Engineering (BPR), Business Strategies, Capital Projects, Clinical Documentation, Compliance Program Development, Computer Science, Emergency Care, Enterprise Systems, Governance Management, Manufacturing Analytics, Occupational Therapy, Quality Assurance (QA), Quality Management, Regulatory Compliance, Regulatory Compliance Management, Risk Management, Systems Development Lifecycle (SDLC), Technical Advice

Preferred Skills:

Job Posting End Date:

05/31/2025

*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.